The Randomized Controlled Cocoa-Appetite Trial
Overview
The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite in humans. In addition the study is designed to test epicatechin, a compound found in cocoa and procyanidins, a class of compounds found in cocoa, for their ability to decrease appetite in humans.
Full Title of Study: “A Pilot Randomized Human Trial on The Effects of Cocoa on Appetite.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: May 2015
Detailed Description
The study is a four-way randomized double-blinded crossover trial with randomization balanced for beverage and lab visit order.
Interventions
- Dietary Supplement: Lo-Flav
- low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage.
- Dietary Supplement: Hi-Flav
- High-flavonoid cocoa powder with 3.8 mg procyanidins per kg of body weight and 0.6 mg Epicatechin per kg of body weight will be consumed as a beverage.
- Dietary Supplement: Epicatechin
- Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage
- Dietary Supplement: Procyanidins
- Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.
Arms, Groups and Cohorts
- Placebo Comparator: Lo-Flav
- Low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage
- Active Comparator: Hi-Flav
- Cocoa powder with 3.8 mg procyanidins per kg of body weight and 0.6 mg Epicatechin per kg of body weight will be consumed as a beverage.
- Active Comparator: Epicatechin
- Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage.
- Active Comparator: Procyanidins
- Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.
Clinical Trial Outcome Measures
Primary Measures
- Appetite as assessed by amount of pizza eaten.
- Time Frame: Two and a half hours
- Amount of pizza eaten to be assessed two and one half hours after ingestion of the beverage.
Secondary Measures
- Appetite as assessed by a Visual Analog Scale
- Time Frame: Two and one half hours
- Visual Analog Scale assessments to be conducted during the two and one half hours after ingestion of the beverage.
Participating in This Clinical Trial
Inclusion Criteria
- stable-weight, as indicated by weight gain or loss of <2% in the past 6 months; – engaging in only mild exercise< twice a week; – moderate alcohol users, <2 drinks/day; – willing to eat pizza. – mentally and physically healthy. Exclusion Criteria:
- smokers regular; – frequent drinkers of coffee, tea or cola sodas, >daily; – underweight or obese (BMI: <18.5 or >30 Kg/m2); – allergies to chocolate, cocoa, green tea, coffee or pizza; – using medication; – interested in registering in the future for the course Health & Nutrition Sciences 2140, Introduction to the U.S. Health Care System, that is often taught by the PI of the proposed study
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Brooklyn College of the City University of New York
- Provider of Information About this Clinical Study
- Principal Investigator: James Greenberg, Associate Professor, Department of Health & Nutrition Sciences, – Brooklyn College of the City University of New York
- Overall Official(s)
- James Greenberg, Ph.D, Principal Investigator, Department of Health & Nutritional Sciences, Brooklyn College of the City University of New York
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